CLOBETASOL PROPIONATE- clobetasol propionate cream

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)

Saadav alates:

NuCare Pharmaceuticals,Inc.

Manustamisviis:

TOPICAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Clobetasol propionate cream is a  super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamicpituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Clobetasol Propionate Cream, USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Toote kokkuvõte:

Clobetasol Propionate Cream USP, 0.05% is supplied in 15-g box (NDC 68071-4592-1) Store cream between 15° and 30°C (59° and 86°F). Clobetasol propionate cream should not be refrigerated. Rx only Manufactured by : Teligent Pharma, Inc. Buena, NJ 08310 76806 Revised: 08/2017

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
NUCARE PHARMACEUTICALS,INC.
----------
CLOBETASOL PROPIONATE CREAM USP, 0.05%
RX ONLY
FOR TOPICAL DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE.
DESCRIPTION
Clobetasol Propionate Cream USP, 0.05% contains the active compound
clobetasol propionate, a
synthetic corticosteroid, for topical dermatologic use. Clobetasol, an
analog of prednisolone, has a
high degree of glucocorticoid activity and a slight degree of
mineralocorticoid activity.
Chemically, clobetasol propionate is (11ß,16ß)-21-chloro-9-
fluoro-11-hydroxy-16-methyl-17-(1-
oxopropoxy)-pregna-1,4- diene-3,20-dione, and it has the following
structural formula:
Clobetasol propionate has the molecular formula C
H
CIFO
and a molecular weight of 467. It is a
white to cream-colored crystalline powder insoluble in water.
Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in
a cream base composed of
cetyl alcohol, citric acid, glycol stearate, lanolin oil,
methylparaben, PEG-8 stearate, polysorbate 60,
propylene glycol, propylparaben, purified water, sodium citrate,
stearyl alcohol, and white petrolatum.
Sodium hydroxide may be used to adjust pH.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, clobetasol propionate has
anti-inflammatory, antipruritic, and
vasoconstrictive properties. The mechanism of the anti-inflammatory
activity of the topical steroids, in
general, is unclear. However, corticosteroids are thought to act by
the induction of phospholipase A
inhibitory proteins, collectively called lipocortins. It is postulated
that these proteins control the
biosynthesis of potent mediators of inflammation such as
prostaglandins and leukotrienes by inhibiting
the release of their common precursor, arachidonic acid. Arachidonic
acid is released from membrane
phospholipids by phospholipase A
.
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many factors,
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including the vehicle and the integrity of the ep